Method and apparatus for patching a tissue opening

ABSTRACT

Disclosed is a closure catheter, for patching a tissue opening such as an atrial septal defect, patent foreman ovale, or the left atrial appendage of the heart. The closure catheter carries a deployable patch and a plurality of tissue anchors, which may be deployed to secure the patch to surrounding tissue. Methods are also disclosed.

This application is a continuation-in-part of application Ser. No.09/399,521, filed Sep. 20, 1999, and now U.S. Pat. No. 6,231,561.

The present invention relates to methods and devices for closing a bodylumen, tissue opening, or cavity and, in particular, for closing anatrial septal defect.

BACKGROUND OF THE INVENTION

Embolic stroke is the nation's third leading killer for adults, and is amajor cause of disability. There are over 700,000 strokes per year inthe United States alone. Of these, roughly 100,000 are hemoragic, and600,000 are ischemic (either due to vessel narrowing or to embolism).The most common cause of embolic stroke emanating from the heart isthrombus formation due to atrial fibrillation. Approximately 80,000strokes per year are attributable to atrial fibrillation. Atrialfibrillation is an arrhythmia of the heart that results in a rapid andchaotic heartbeat that produces lower cardiac output and irregular andturbulent blood flow in the vascular system. There are over five millionpeople worldwide with atrial fibrillation, with about four hundredthousand new cases reported each year. Atrial fibrillation is associatedwith a 500 percent greater risk of stroke due to the condition. Apatient with atrial fibrillation typically has a significantly decreasedquality of life due, in part, to the fear of a stroke, and thepharmaceutical regimen necessary to reduce that risk.

For patients who develop atrial thrombus from atrial fibrillation, theclot normally occurs in the left atrial appendage (LAA) of the heart.The LAA is a cavity which looks like a small finger or windsock andwhich is connected to the lateral wall of the left atrium between themitral valve and the root of the left pulmonary vein. The LAA normallycontracts with the rest of the left atrium during a normal heart cycle,thus keeping blood from becoming stagnant therein, but often fails tocontract with any vigor in patients experiencing atrial fibrillation dueto the discoordinate electrical signals associated with AF. As a result,thrombus formation is predisposed to form in the stagnant blood withinthe LAA.

Blackshear and Odell have reported that of the 1288 patients withnon-rheumatic trial fibrillation involved in their study, 221 (17%) hadthrombus detected in the left atrium of the heart. Blackshear J L, OdellJ A., Appendage Obliteration to Reduce Stroke in Cardiac SurgicalPatients With Atrial Fibrillation. Ann Thorac. Surg., 1996.61(2):755-9.Of the patients with atrial thrombus, 201 (91%) had the atrial thrombuslocated within the left atrial appendage. The foregoing suggests thatthe elimination or containment of thrombus formed within the LAA ofpatients with atrial fibrillation would significantly reduce theincidence of stroke in those patients.

Pharmacological therapies for stroke prevention such as oral or systemicadministration of warfarin or the like have been inadequate due toserious side effects of the medications and lack of patient compliancein taking the medication. Invasive surgical or thorascopic techniqueshave been used to obliterate the LAA, however, many patients are notsuitable candidates for such surgical procedures due to a compromisedcondition or having previously undergone cardiac surgery. In addition,the perceived risks of even a thorascopic surgical procedure oftenoutweigh the potential benefits. See Blackshear and Odell, above. Seealso Lindsay B D., Obliteration of the Left Atrial Appendage: A ConceptWorth Testing, Ann Thorac. Surg., 1996.61(2):515.

Despite the various efforts in the prior art, there remains a need for aminimally invasive method and associated devices for reducing the riskof thrombus formation in the left atrial appendage.

Other conditions which would benefit from a tissue aperture closurecatheter are tissue openings such as an atrial septal defect. Ingeneral, the heart is divided into four chambers, the two upper beingthe left and right atria and the two lower being the left and rightventricles. The atria are separated from each other by a muscular wall,the interatrial septum, and the ventricles by the interventricularseptum.

Either congenitally or by acquisition, abnormal openings, holes orshunts can occur between the chambers of the heart or the great vessels(interatrial and interventricular septal defects or patent ductusarteriosus and aorthico-pulmonary window respectively), causing shuntingof blood through the opening. The ductus arteriosus is the prenatalcanal between the pulmonary artery and the aortic arch which normallycloses soon after birth. The deformity is usually congenital, resultingfrom a failure of completion of the formation of the septum, or wall,between the two sides during fetal life when the heart forms from afolded tube into a four-chambered, two unit system.

These deformities can carry significant sequelae. For example, with anatrial septal defect, blood is shunted from the left atrium of the heartto the right, producing an over-load of the right heart. In addition toleft-to-right shunts such as occur in patent ductus arteriosus from theaorta to the pulmonary artery, the left side of the heart has to workharder because some of the blood which it pumps will recirculate throughthe lungs instead of going out to the rest of the body. The ill effectsof these lesions usually cause added strain on the heart with ultimatefailure if not corrected.

Previous extracardiac (outside the heart) or intracardiac septal defectshave required relatively extensive surgical techniques for correction.To date the most common method of closing intracardiac shunts, such asatrial-septal defects and ventricular-septal defects, entails therelatively drastic technique of open-heart surgery, requiring openingthe chest or sternum and diverting the blood from the heart with the useof a cardiopulmonary bypass. The heart is then opened, the defect issewn shut by direct suturing with or without a patch of syntheticmaterial (usually of Dacron, Teflon, silk, nylon or pericardium), andthen the heart is closed. The patient is then taken off thecardiopulmonary bypass machine, and then the chest is closed.

In place of direct suturing, closures of interauricular septal defectsby means of a mechanical prosthesis have been disclosed.

U.S. Pat. No. 3,874,388 to King, et al. relates to a shunt defectclosure system including a pair of opposed umbrella-like elements lockedtogether in a face to face relationship and delivered by means of acatheter, whereby a defect is closed. U.S. Pat. No. 5,350,399 toErlebacher, et al. relates to a percutaneous arterial puncture sealdevice also including a pair of opposed umbrella-like elements and aninsertion tool.

U.S. Pat. No. 4,710,192 to Liotta, et al. relates to a vaulted diaphragmfor occlusion in a descending thoracic aorta.

U.S. Pat. No. 5,108,420 to Marks relates to an aperture occlusion deviceconsisting of a wire having an elongated configuration for delivery tothe aperture, and a preprogrammed configuration including occlusionforming wire segments on each side of the aperture.

U.S. Pat. No. 4,007,743 to Blake relates to an opening mechanism forumbrella-like intravascular shunt defect closure device having foldableflat ring sections which extend between pivotable struts when the deviceis expanded and fold between the struts when the device is collapsed.

Notwithstanding the foregoing, there remains a need for a transluminalmethod and apparatus for correcting intracardiac septal defects, whichenables a patch to placed across a septal defect to inhibit or preventthe flow of blood therethrough.

SUMMARY OF THE INVENTION

The present invention provides a closure catheter and methods forclosing an opening in tissue, a body lumen, hollow organ or other bodycavity. The catheter and methods of its use are useful in a variety ofprocedures, such as treating (closing) wounds and naturally orsurgically created apertures or passageways. Applications include, butare not limited to, atrial septal defect closure, patent ductusarteriosis closure, aneurysm isolation and graft and/or bypassanastomosis procedures.

There is provided in accordance with one aspect of the presentinvention, a method of patching an intracardiac septal defect such as anatrial septal defect. The method comprises the steps of providing acatheter having an elongate flexible body with a proximal end and adistal end, a patch and at least two anchors removably carried by thedistal end. The distal end is advanced to a position near the atrialseptal defect, and the patch is positioned across the defect. Theanchors are thereafter deployed from the catheter to secure the patchacross the defect.

In one embodiment, the positioning step comprises enlarging the crosssection of the patch from a reduced profile for advancing the catheter,to an enlarged profile for patching the defect. The positioning stepcomprises inclining at least one patch support from an axial orientationto an inclined orientation to position the patch across the defect. Thepositioning step preferably comprises inclining at least three patchsupports from an axial orientation to an inclined orientation toposition the patch across the defect. In one embodiment, the deployingthe anchors step comprises advancing the anchors distally through thepatch and into tissue adjacent the defect to secure the patch across thedefect.

In accordance with another aspect of the present invention, there isprovided a method of closing an opening in a subcutaneous tissue plane.The method comprises the steps of providing a catheter having a patchand at least one anchor. The catheter is advanced to the opening, andthe patch is positioned across the opening. The anchor is advanced intotissue to secure the patch across the opening. Preferably, the advancingthe anchor step comprises advancing at least three anchors into thetissue to secure the patch across the opening. The opening may be anaturally occurring opening such as an atrial septal defect, or asurgically created opening.

In accordance with a further aspect of the present invention, there isprovided a deployment catheter for deploying a patch across a tissueaperture. The deployment catheter comprises an elongate body having aproximal end and a distal end. At least one patch support is provided onthe body for removably carrying a patch. At least one anchor support isalso provided for removably carrying at least one anchor. The anchorsupport is movable between an axial orientation and an inclinedorientation with respect to a longitudinal axis of the body. In oneembodiment, the anchor support is hingably connected to the patchsupport. The anchor support and patch support may also be the samestructure, such that the patch is carried by the anchor supports.Preferably, at least three anchor supports and/or at least three patchsupports are provided.

In accordance with a further aspect of the present invention, there isprovided a patch deployment catheter for deploying a patch across anopening. The catheter comprises an elongate body, having a proximal endand a distal end. At least two supports are provided on the catheter,movable between an axial orientation and an inclined orientation. Eachsupport comprises a proximal section, a distal section and a hingein-between. A control is provided on the catheter for moving the hingeradially outwardly from a first position for introducing the catheter toa site in the body to a second position for deploying the patch at thesite. The supports are in the axial orientation when the hinge is in thefirst position.

In one embodiment, the elongate body is flexible. Preferably, at leastone tissue anchor is carried by the proximal section of each support. Atleast one patch is preferably carried by the distal section of eachsupport. In one embodiment, the patch comprises a tissue ingrowthsurface.

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anterior illustration of a heart, with the proximal partsof the great vessels.

FIG. 2 is a schematic cross section through the heart with a transeptalcatheter deployed through the septum and a closure catheter extendinginto the LAA.

FIG. 3A is an enlarged perspective view of the distal end of a closurecatheter in accordance with the present invention.

FIG. 3B is a cross section taken along the lines 3B—3B of FIG. 3A.

FIG. 4 is a partial cross-sectional view of a tissue anchor andintroducer, positioned within an anchor guide in accordance with thepresent invention.

FIG. 5 is an exploded view of a tissue anchor and introducer inaccordance with one aspect of the invention.

FIG. 6A is a schematic illustration of a tissue anchor and introduceradvancing into a tissue surface.

FIG. 6B is an illustration as in FIG. 6A, with the anchor positionedwithin the tissue and the introducer partially retracted.

FIG. 6C is an illustration as in FIG. 6B, with the introducer fullyretracted and the anchor positioned within the tissue.

FIG. 7 shows a schematic view of a closure catheter disposed within theopening of the LAA.

FIG. 8 is a schematic illustration of the opening of the LAA as in FIG.7, with the anchor guides in an inclined orientation.

FIG. 9 is a schematic illustration as in FIG. 8, with tissue anchorsdeployed from the anchor guides.

FIG. 10 is a schematic illustration as in FIG. 9, with the anchor guidesretracted into an axial orientation.

FIG. 11 is a schematic illustration as in FIG. 10, with the closurecatheter retracted and the LAA drawn closed using the tissue anchors.

FIG. 12 is a perspective view of a closure catheter in accordance withthe present invention positioned within a tissue aperture, such as anatrial septal defect.

FIG. 13 is a side elevational partial cross-section of the catheter ofFIG. 12, in an anchor deployment orientation within the aperture.

FIG. 14 is a side elevational partial cross-section as in FIG. 13, withthe deployment catheter withdrawn from the aperture.

FIG. 15 is a side elevational cross section through the aperture, whichhas been closed in accordance with the present invention.

FIG. 16 is a perspective view of a closure catheter in accordance withthe present invention, carrying an aperture patch.

FIG. 17 is a cross-sectional view through the catheter of FIG. 16, showndeploying a patch across a tissue aperture.

FIG. 18 is a perspective view of a buckling rivet type anchor inaccordance with the present invention.

FIG. 19 is a perspective view of the buckling rivet of FIG. 18, carriedby an introducer.

FIG. 20 is a cross-sectional schematic view of a buckling rivet of thetype shown in FIG. 18, deployed on a tissue membrane.

FIGS. 21A-21G are alternate tissue anchors for use with the closurecatheter of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

For simplicity, the present invention will be described primarily in thecontext of a left atrial appendage closure procedure. However, thedevice and methods herein are readily applicable to a wider variety ofclosure or attachment procedures, and all such applications arecontemplated by the present inventors. For example, additional heartmuscle procedures such as atrial septal defect closure and patent ductusarteriosis closure are contemplated. Vascular procedures such asisolation or repair of aneurysms, anastomosis of vessel to vessel orvessel to prosthetic tubular graft (e.g., PTFE or Dacron tubes, with orwithout wire support structures as are well known in the art) joints mayalso be accomplished using the devices of the present invention.Attachment of implantable prostheses, such as attachment of the annulusof a prosthetic tissue or mechanical heart valve may be accomplished. Avariety of other tissue openings, lumens, hollow organs and surgicallycreated passageways may be closed, patched or reduced in volume inaccordance with the present invention. For example, an opening in atissue plane may be closed or patched, such as by attaching a fabric ortissue sheet across the opening. In one specific application, the deviceof the present invention is used to anchor a fabric patch to close anatrial septal defect. The target aperture or cavity may be accessedtransluminally (e.g., vascular catheter or endoscope) or through solidtissue, such as transmural, percutaneous or other approach. The presentinvention may also be used in an open surgical procedure such as toclose the left atrial appendage during open heart surgery to correct oraddress a different condition. In another example, the device isadvanced through the percutaneous opening and used to close a vascularpuncture such as a femoral artery access site for a PTA or otherdiagnostic or therapeutic interventional procedure. Adaptation of thedevices and methods disclosed herein to accomplish procedures such asthe foregoing will be apparent to those of skill in the art in view ofthe disclosure herein.

Referring to FIG. 1, a heart 10 is illustrated to show certain portionsincluding the left ventricle 12, the left atrium 14, the left atrialappendage (LAA) 16, the pulmonary artery 18, the aorta 20, the rightventricle 22, the right atria 24, and the right atrial appendage 26. Asis understood in the art, the left atrium 14 is located above the leftventricle 12 and the two are separated by the mitral valve (notillustrated). The LAA 16 is normally in fluid communication with theleft atrium 14 such that blood flows in and out of the LAA 16 as theheart 10 beats.

In accordance with the present invention, a closure catheter 38 isadvanced through the heart and into the LAA. In general, the closurecatheter 38 is adapted to grasp tissue surrounding the opening to theLAA, and retract it radially inwardly to reduce the volume of and/orclose the LAA. The LAA is thereafter secured in its closed orientation,and the closure catheter 38 is removed. Specific aspects of oneembodiment of the closure catheter in accordance with the presentinvention are described in greater detail below.

The LAA may be accessed through any of a variety of pathways as will beapparent to those of skill in the art. Transeptal access, ascontemplated by FIG. 2, may be achieved by introducing a transeptalcatheter through the femoral or jugular vein, and transluminallyadvancing the catheter into the right atrium. Once in the right atrium,a long hollow needle with a preformed curve and a sharpened distal tipis forcibly inserted through the fossa ovalis. A radiopaque contrastmedia may then be injected through the needle to allow visualization andensure placement of the needle in the left atrium, as opposed to beingin the pericardial space, aorta, or other undesired location.

Once the position of the needle in the left atrium is confirmed, thetranseptal catheter is advanced into the left atrium. The closurecatheter 38 may then be advanced through the transeptal catheter 30, andsteered or directed into the left atrial appendage. Alternativeapproaches include venous transatrial approaches such as transvascularadvancement through the aorta and the mitral valve. In addition, thedevices of the present invention can be readily adapted for use in anopen heart surgical procedure, although transluminal access is presentlypreferred.

Thus, referring to FIG. 2, a transeptal catheter 30 has a proximal end32 and a distal end 34. The distal end 34 of the transeptal catheter 30has breached the septum 40 of the patient's heart 10 and is disposedadjacent the opening 42 of the patient's LAA 16. The distal end 36 of aclosure catheter 38 extends from the distal end 34 of the transeptalcatheter 30 and into the LAA 16.

At the proximal end 46 of the transeptal catheter 30, a luer connectorcoupled to a hemostasis valve 48 prevents the egress of blood from acentral lumen of the transeptal catheter 30. The proximal end 50 of theclosure catheter 38 extends proximally from the hemostasis valve 48.Additional details concerning the use and design of transeptal accesscatheters are well known in the art and will not be discussed furtherherein.

Referring to FIGS. 2 and 3, the closure catheter 38 thus has a proximalend 50, a distal end 36, and an elongate flexible tubular body 52extending therebetween. The axial length of the closure catheter 38 canbe varied, depending upon the intended access point and pathway. For afemoral vein-transeptal approach, the closure catheter 38 generally hasan axial length within the range of from about 100 cm to about 140 cm,and, in one embodiment, about 117 cm.

The outside diameter of the flexible body 52 can also be varied,depending upon the number of internal lumen and other functionalities aswill be understood by those of skill in the art. In one embodiment, theoutside diameter is about 12 FR (0.156 inches), and closure cathetersare contemplated to have OD's generally within the range of from about0.078 inches to about 0.250 inches. Diameters outside of the above rangemay also be used, provided that the functional consequences of thediameter are acceptable for the intended application of the catheter.

For example, the lower limit of the outside diameter for tubular body 52in a given application will be a function of the number of fluid orother functional lumen contained within the catheter. In addition,tubular body 52 must have sufficient pushability to permit the catheterto be advanced to its target location within the heart without bucklingor undesirable bending. The ability of the tubular body 52 to transmittorque may also be desirable, such as in embodiments in which the tissueanchor deployment guides are not uniformly circumferentially distributedabout the distal end 36 of the catheter. Optimization of the outsidediameter of the catheter, taking into account the flexibility,pushability and torque transmission characteristics can be accomplishedthrough routine experimentation using conventional catheter designtechniques well known to those of skill in the art.

The flexible body 52 can be manufactured in accordance with any of avariety of known techniques. In one embodiment, the flexible body 52 isextruded from any of a variety of materials such as HDPE, PEBAX, nylon,polyimide, and PEEK. Alternatively, at least a portion or all of thelength of tubular body 52 may comprise a spring coil, solid walledhypodermic needle or other metal tubing, or braided reinforced wall, asare known in the art.

The proximal end 50 of the closure catheter 38 is provided with amanifold 51, having a plurality of access ports. Generally, manifold 51is provided with an access port 53 which may be used as a guidewire portin an over the wire embodiment, and a deployment wire port 57.Additional access ports such as a contrast media introduction port 55,or others may be provided as needed, depending upon the functionalrequirements of the catheter.

The tubular body 52 has at least a first actuator lumen 54, for axiallymovably receiving an actuator 56. Actuator 56 extends between a proximalend 64 at about the proximal end of the closure catheter, and a distalend 66 at or near the distal end 36 of the closure catheter 38. Thedistal end 66 of the actuator 56 is secured to a cap 68. In theillustrated embodiment, the actuator lumen 54 is in communication withthe access port 53 to permit the actuator 56 to extend proximallytherethrough.

Actuator 56 can have a variety of forms, depending upon the constructionof the anchor supports 62 on the distal end 36 of the closure catheter38. In general, the catheter in the area of the anchor supports 62should have a crossing profile of no more than about 14 French fortransluminal advancement and positioning. However, the anchor supportsmust then be capable of directing tissue anchors into the wall of thecavity or lumen which may have an inside diameter on the order of about1.5 cm to about 3 cm in the case of the LAA in an average adult. Thedevice of the present invention can be readily scaled up or downdepending upon the intended use, such as to accommodate a 5 cm to 10 cmcavity in GI tract applications or 5 mm to about 2 cm for vascularapplications. For this purpose, the anchor supports are preferablymoveable between a reduced cross sectional orientation and an enlargedcross sectional orientation to aim at, and, in some embodiments, contactthe target tissue surface.

One convenient construction to accomplish the foregoing is for eachanchor support 62 to take the form of a lever arm structure which ispivotably connected at one end to the catheter body. This constructionpermits inclination of the anchor support throughout a continuous rangeof outside diameters which may be desirable to aim the anchor andaccommodate different treatment sites and/or normal anatomical variationwithin the patient population.

A laterally moveable anchor support can be moved between an axialorientation and an inclined orientation in a variety of ways. Oneconvenient way is through the use of a pull wire or other actuator whichincreases the diameter of the deployment zone of the catheter inresponse to an axial shortening of fixed length moveable segments asdisclosed in more detail below. For this construction, the actuator willbe under pulling tension during actuation. Any of a variety ofstructures such as polymeric or metal single or multiple strand wires,ribbons or tubes can be used. In the illustrated embodiment, theactuator 56 comprises stainless steel tube, having an outside diameterof about 0.025 inches.

A pull wire can alternatively be connected to the radially outwardlyfacing surface and preferably near the distal end of each anchorsupport, and each anchor support is hingably attached at its proximalend to the catheter. Proximal traction on the pull wire will cause theanchor support to incline radially outwardly in the distal direction,and toward the target tissue.

In an alternate construction, the anchor support is inclined under acompressive force on the actuator 56. For example, the embodimentdescribed in detail below can readily be converted to a push actuatedsystem by axially immovable fixing the distal end of the anchor guideassembly to the catheter and slideably pushing the proximal end of theanchor guide assembly in the distal direction to achieve axialcompression as will become apparent from the discussion below.

Push wire actuators have different requirements, than pull actuatorsystems, such as the ability to propagate a sufficient compressive forcewithout excessive compression bending or friction. Thus, solid corewires or tubular structures may be preferred, as well as larger outsidediameters compared to the minimum requirements in a pull actuatedsystem. Thus, the inside diameter of the actuator lumen 57 may bevaried, depending upon the actuator system design. In the illustratedembodiment, the actuator lumen 57 has an ID of about 0.038 inches, toslideably accommodate the 0.025 inch OD actuator 56.

A radially outwardly directed force on the anchor supports 62 can beprovided by any of a variety of alternative expansion structures,depending upon desired performance and construction issues. For example,an inflatable balloon can be positioned radially inwardly from aplurality of hingably mounted anchor supports 62, and placed incommunication with actuator lumen 54 which may be used as an inflationlumen. Any of a variety of balloon materials may be used, ranging inphysical properties from latex for a highly compliant, low pressuresystem to PET for a noncompliant high pressure and consequently highradial force system, as is understood in the balloon angioplasty arts.

The tubular body 52 may additionally be provided with a guidewire lumen57, or a guidewire lumen 57 may extend coaxially throughout the lengthof a tubular actuator 56 as in the illustrated embodiment.

The tubular body 52 may additionally be provided with a deployment lumen58, for axially movably receiving one or more deployment elements 60such as a wire, or suture for deploying one or more tissue anchors 90into the target tissue 110. Deployment force for deploying the tissueanchors 90 can be designed to be in either the distal or proximaldirection, and many of the considerations discussed above in connectionwith the actuator 56 and corresponding actuator lumen 54 apply to thedeployment system as well. In the illustrated embodiment, deployment ofthe tissue anchors 90 is accomplished by proximal retraction on thedeployment element 60 which, in turn, retracts deployment wire 106.Pushability is thus not an issue, and common suture such as 0.008 inchdiameter nylon line may be used. For this embodiment, deployment lumen58 has an inside diameter of about 0.038 inches. The deployment lumen 58can be sized to receive either a single deployment element 60, or aplurality of deployment elements 106 such as a unique suture for eachtissue anchor.

The distal end 36 of the closure catheter 38 is provided with one ormore anchor supports 62, for removably carrying one or more tissueanchors. Preferably, two or more anchor supports 62 are provided, and,generally, in a device intended for LAA closure, from about 3 to about12 anchor supports 62 are provided. In the illustrated embodiment, sixanchor supports 62 are evenly circumferentially spaced around thelongitudinal axis of the closure catheter 38.

Each anchor support 62 comprises a surface 63 for slideably retaining atleast one tissue anchor, and permitting the tissue anchor to be aimed bymanipulation of a control on the proximal end 50 of the closure catheter38. Specific details of one embodiment of the anchor support 62 having asingle anchor therein will be discussed below. Multiple anchors, such astwo or three or more, can also be carried by each anchor support forsequential deployment.

The anchor supports 62 are movable between an axial orientation and aninclined orientation, in response to manipulation of a proximal control.The proximal control can take any of a variety of forms, such as sliderswitches or levers, rotatable levers or knobs, or the like, dependingupon the desired performance. For example, a rotatable knob control canpermit precise control over the degree of inclination of the anchorsupports 62. A direct axial slider control, such as a knob or other gripdirectly mounted to the actuator 56 will optimize tactile feedback ofevents such as the anchor supports 62 coming into contact with thetarget tissue.

Each of the illustrated anchor supports 62 comprises at least a proximalsection 70, a distal section 72, and a flex point 74. See FIG. 4. Thedistal end 73 of each distal section 72 is movably connected to thecatheter body or the cap 68. In this embodiment, proximal retraction ofthe actuator 56 shortens the axial distance between the proximal end 71of the proximal section 70 and the distal end 73 of distal section 72,forcing the flex point 74 radially outwardly from the longitudinal axisof the closure catheter 38. In this manner, proximal retraction of theactuator 56 through a controlled axial distance will cause a predictableand controlled increase in the angle between the proximal and distalsections 70 and 72 of the anchor support 62 and the longitudinal axis ofthe catheter. This is ideally suited for aiming a plurality of tissueanchors at the interior wall of a tubular structure, such as a vessel orthe left atrial appendage.

Referring to FIG. 4, there is illustrated an enlarged detailed view ofone anchor support 62 in accordance with the present invention. Theproximal section 70 and distal section 72 preferably comprise a tubularwall 76 and 78 joined at the flex point 74. In one embodiment, theproximal section 70 and distal section 72 may be formed from a singlelength of tubing, such as by laser cutting, photolithography, orgrinding to separate the proximal section 70 from the distal section 72while leaving one or two or more integrally formed hinges at flex point74. Any of a variety of polymeric or metal tubing may be utilized forthis purpose, including stainless steel, Nitinol or other super-elasticalloys, polyimide, or others which will be appreciated by those of skillin the art in view of the disclosure herein.

In the illustrated six tube embodiment, the proximal section 70 anddistal section 72 are formed from a length of PEEK tubing having aninside diameter of about 0.038 inches, an outside diameter of about0.045 inches and an overall length of about 1.4 inches. In general, ifmore than six anchor supports 62 are used, the diameter of each will becommensurately less than in the six tube embodiment for any particularapplication. When the proximal section 70 and the distal section 72 arecoaxially aligned, a gap having an axial length of about 0.030 isprovided therebetween. In the illustrated embodiment, the proximalsection 70 and distal section 72 are approximately equal in lengthalthough dissimilar lengths may be desirable in certain embodiments. Thelength of the portion of the anchor support 62 which carries the tissueanchor 90 is preferably selected for a particular procedure or anatomyso that the anchor support 62 will be inclined at an acceptable launchangle when the deployment end of the anchor support 62 is brought intocontact with the target tissue 110. Lengths from the hinge to thedeployment end of the anchor support 62 within the range of from about0.5 cm to about 1.5 cm are contemplated for the LAA applicationdisclosed herein.

For certain applications, the proximal section 70 is at least about 10%and preferably at least about 20% longer than the distal section 72. Forexample, in one device adapted for the LAA closure application, theproximal section 70 in a six anchor device has a length of about 0.54inches, and the distal section 72 has a length of about 0.40 inches.Each anchor support has an OD of about 0.045 inches. As with previousembodiments, the functional roles and/or the dimensions of the proximaland distal sections can be reversed and remain within the scope of thepresent invention. Optimization of the relative lever arm lengths can bedetermined for each application taking into account a variety ofvariables such as desired device diameter, target lumen or tissueaperture diameter, launch angle and desired pull forces for aiming anddeployment.

The proximal end 71 of the proximal section 70 and distal end 73 ofdistal section 72 are movably secured to the closure catheter 38 in anyof a variety of ways which will be apparent to those of skill in the artin view of the disclosure herein. In the illustrated embodiment, eachanchor support 62 comprises a four segment component which may beconstructed from a single length of tubing by providing an intermediateflex point 74, a proximal flex point 80 and a distal flex point 82.Distal flex point 82 provides a pivotable connection between the anchorsupport 62 and a distal connection segment 84. The distal connectionsegment 84 may be secured to the distal end of actuator 56 by any of avariety of techniques, such as soldering, adhesives, mechanical interfitor others, as will be apparent to those of skill in the art. In theillustrated embodiment, the distal connection segment 84 is secured tothe distal end 66 of the actuator 56 by adhesive bonding.

The proximal flex point 80 in the illustrated embodiment separates theproximal section 70 from a proximal connection segment 86, which isattached to the catheter body 52. In this construction, proximal axialretraction of the actuator 56 with respect to the tubular body 52 willcause the distal connection segment 84 to advance proximally towards theproximal connection segment 86, thereby laterally displacing the flexpoint 74 away from the longitudinal axis of the closure catheter 38. Asa consequence, each of the proximal section 70 and the distal section 72are aimed at an angle which is inclined outwardly from the axis of theclosure catheter 38.

In general, each flex point 80, 82 includes a hinge 81, 83 which may be,as illustrated, a strip of flexible material. The hinges 81 and 83 arepreferably positioned on the inside radius of the flex points 80, 82,respectively, for many construction materials. For certain materials,such as Nitinol or other superelastic alloys, the hinges 81 and 83 canbe positioned at approximately 90° or 180° or other angle around thecircumference of the tubular anchor guide from the inside radius of theflex point.

A tissue anchor 90 is illustrated as positioned within the distalsection 72, for deployment in a generally proximal direction.Alternatively, the anchor 90 can be loaded in the proximal section 70,for distal deployment. A variety of tissue anchors can be readilyadapted for use with the closure catheter 38 of the present invention,as will be appreciated by those of skill in the art in view of thedisclosure herein. In the illustrated embodiment, the tissue anchor 90comprises a tubular structure having a body 92, and one or more barbs94. Tubular body 92 is coaxially movably disposed about an introducer96. Introducer 96 has a proximal section 98, and a sharpened distal tip100 separated by an elongate distal section 102 for slideably receivingthe tissue anchor 90 thereon.

The tissue anchor 90 in the illustrated embodiment comprises a tubularbody 92 having an axial length of about 0.118 inches, an inside diameterof about 0.017 inches and an outside diameter of about 0.023 inches. Twoor more barbs 94 may be provided by laser cutting a pattern in the wallof the tube, and bending each barb 94 such that it is biased radiallyoutwardly as illustrated. The tissue anchor 90 may be made from any of avariety of biocompatible metals such as stainless steel, Nitinol,Elgiloy or others known in the art. Polymeric anchors such as HDPE,nylon, PTFE or others may alternatively be used. For embodiments whichwill rely upon a secondary closure structure such as staples, sutures orclips to retain the LAA or other cavity closed, the anchor may comprisea bioabsorbable or dissolvable material so that it disappears after aperiod of time. An anchor suture 108 is secured to the anchor.

In one embodiment of the invention, the introducer 96 has an axiallength of about 0.250 inches. The proximal section 98 has an outsidediameter of about 0.023 inches and an axial length of about 0.100inches. The distal section 102 has an outside diameter of about 0.016inches and an axial length of about 0.150 inches. The outside diametermismatch between the proximal section 98 and the distal section 102provides a distally facing abutment 104, for supporting the tubular body92 of tissue anchor 90, during the tissue penetration step. A deploymentwire (e.g., a suture) 106 is secured to the proximal end 98 of theintroducer 96. The introducer 96 may be made in any of a variety ofways, such as extrusion or machining from stainless steel tube stock.

Referring to FIGS. 6A-6C, introduction of the tissue anchor 90 intotarget tissue 110 is illustrated following inclination of the anchorsupport 62 with respect to the longitudinal axis of the closure catheter38. Proximal retraction of the deployment wire 106 causes the tissueanchor 90 and introducer 96 assembly to travel axially through thedistal section 72, and into the tissue 110. Continued axial traction onthe deployment wire 106 causes the longitudinal axis of the introducer96 to rotate, such that the introducer 96 becomes coaxially aligned withthe longitudinal axis of the proximal section 70. Continued proximaltraction on the deployment wire 106 retracts the introducer 96 from thetissue anchor 90, leaving the tissue anchor 90 in place within thetissue. The anchor suture 108 remains secured to the tissue anchor 90,as illustrated in FIG. 6C.

In use, the closure catheter 38 is percutaneously introduced into thevascular system and transluminally advanced into the heart and,subsequently, into the left atrial appendage using techniques which areknown in the art. Referring to FIG. 7, the distal end 36 of the closurecatheter 38 is positioned at about the opening of the LAA 16, and theposition may be confirmed using fluoroscopy, echocardiography, or otherimaging. The actuator 56 is thereafter proximally retracted, to inclinethe anchor supports 62 radially outwardly from the longitudinal axis ofthe closure catheter 38, as illustrated in FIG. 8. Preferably, the axiallength of the proximal section 70 of each anchor support 62, incombination with the angular range of motion at the proximal flex point80, permit the flex point 74 to be brought into contact with the tissuesurrounding the opening to the LAA. In general, this is preferablyaccomplished with the distal section 72 inclined at an angle within arange of from about 45° to about 120° with respect to the longitudinalaxis of the closure catheter 38. Actuator 56 may be proximally retracteduntil the supports 62 are fully inclined, or until tactile feedbackreveals that the anchor supports 62 have come into contact with thesurrounding tissue 110.

Following inclination of the anchor supports 62, the deployment wire 106is proximally retracted thereby advancing each of the tissue anchors 90into the surrounding tissue 110 as has been discussed. See FIG. 9. Theanchor supports 62 are thereafter returned to the first, axial position,as illustrated in FIG. 10, for retraction from the left atrialappendage. Proximal retraction on the anchor sutures 108 such as througha tube, loop or aperture will then cause the left atrial appendage wallto collapse as illustrated in FIG. 11. Anchor sutures may thereafter besecured together using any of a variety of conventional means, such asclips, knots, adhesives, or others which will be understood by those ofskill in the art. Alternatively, the LAA may be sutured, pinned, stapledor clipped shut, or retained using any of a variety of biocompatibleadhesives.

In an alternate embodiment, a single suture is slideably connected tothe at least three and preferably five or more anchors such thatproximal retraction of the suture following deployment of the anchorsdraws the tissue closed in a “purse string” fashion. A similar techniqueis illustrated in FIGS. 31A and 31B in U.S. Pat. No. 5,865,791 toWhayne, et al., the disclosure of which is incorporated in its entiretyherein by reference.

The foregoing closure techniques may be accomplished through the closurecatheter, or through the use of a separate catheter. The closurecatheter may thereafter be proximally retracted from the patient, andthe percutaneous and vascular access sites closed in accordance withconventional puncture closure techniques.

In accordance with a further aspect of the present invention, theclosure catheter 38 with modifications identified below and/or apparentto those of skill in the art in view of the intended application, may beutilized to close any of a variety of tissue apertures. These include,for example, atrial septal defects, ventricle septal defects, patentductus arteriosis, patent foreman ovale, and others which will beapparent to those of skill in the art. Tissue aperture closuretechniques will be discussed in general in connection with FIGS. 12-17.

Referring to FIG. 12, there is schematically illustrated a fragmentaryview of a tissue plane 120 such as a septum or other wall of the heart.Tissue plane 120 contains an aperture 122, which is desirably closed.The closure catheter 38 is illustrated such that at least a portion ofthe distal end 36 extends through the aperture 122. Although the presentaspect of the invention will be described in terms of a retrograde orproximal tissue anchor advancement from the back side of the tissueplane, the anchor deployment direction can readily be reversed by one ofordinary skill in the art in view of the disclosure herein, and themodifications to the associated method would be apparent in the contextof a distal anchor advancement embodiment. In general, the proximalanchor advancement method, as illustrated, may desirably assist incentering of the catheter within the aperture, as well as permittingpositive traction to be in the same direction as anchor deployment.

Closure catheter 38 is provided with a plurality of anchor supports 62as have been described previously herein. In an embodiment intended foratrial septal defect closure, anywhere within the range of from about 3to about 12 anchor supports 62 may be utilized.

Referring to FIG. 13, each anchor support 62 comprises a proximalsection 70, a distal section 72, and a hinge or flex point 74therebetween as has been previously discussed. At least one anchor 90 iscarried by each anchor support 62, such as within the tubular distalsection 72 in the context of a proximal deployment direction embodiment.Anchor 90 is connected to an anchor suture 108 as has been discussed. Inthe illustrated embodiment, the anchor suture 108 extends along theoutside of the anchor support 62 and into the distal opening of a lumenin tubular body 52. The anchor sutures 108 may, at some point, be joinedinto a single element, or distinct anchor sutures 108 may extendthroughout the length of the catheter body to the proximal end thereof.

As shown in FIG. 13, the anchor support 62 is advanced from a generallyaxially extending orientation to an inclined orientation to facilitatedeployment of the anchor 90 into the tissue plane 120 adjacent aperture122. Preferably, the geometry of the triangle defined by distal section72, proximal section 70 and the longitudinal axis of the catheter isselected such that the plurality of anchors 90 will define a roughlycircular pattern which has a greater diameter than the diameter ofaperture 122. Thus, the length of proximal section 70 will generally begreater than the approximate radius of the aperture 122.

In general, for atrial septal defect applications, the circle which bestfits the anchor deployment pattern when the distal section 72 isinclined to its operative angle will have a diameter within the range offrom about 0.5 centimeters to about 3 centimeters. Dimensions beyondeither end of the foregoing range may be desirable to correct defects ofunusual proportions. In addition, it is not necessary that the anchorsdefine a circular pattern when deployed into the tissue plane 120.Non-circular patterns such as polygonal, elliptical, oval or other, maybe desirable, depending upon the nature of the aperture 122 to beclosed.

FIG. 13 illustrates the anchors 90 partially deployed into or throughthe tissue plane 120. In general, the anchors 90 may either be designedto reside within the tissue plane 120 such as for locations of theaperture 120 which are adjacent relatively thick tissues. Alternatively,the tissue anchor 90 may be designed to reside on one side of the tissueplane 120, and attached to a suture which extends through the tissueplane 120 as illustrated in FIGS. 14 and 15.

Referring to FIG. 14, the closure catheter 38 is illustrated as returnedto the generally axial orientation and proximally retracted through theaperture 122 following deployment of a plurality of tissue anchors 90.The anchor sutures 108 may thereafter be proximally retracted from theproximal end of the closure catheter 38, thereby drawing the tissuesurrounding aperture 122 together to close the aperture. The anchorsutures 108 may thereafter be secured together in any of a variety ofmanners, such as by clamping, knotting, adhesives, thermal bonding orthe like.

In the illustrated embodiment, the closure catheter 38 carries adetachable clamp 124 which may be deployed from the distal end of theclosure catheter 38 such as by a push wire, to retain the anchor sutures108. The clamp 124 may be an annular structure with an aperture thereinfor receiving the anchor sutures 108. The clamp is carried on thecatheter in an “open” position and biased towards a “closed” position inwhich it tightens around the sutures 108. A ring of elastomeric polymeror a shape memory metal alloy may be used for this purpose. Any of avariety of clamps, clips, adhesives, or other structures may be utilizedto secure the anchor sutures 108 as will be appreciated by those ofskill in the art in view of the disclosure herein. Anchor sutures 108may thereafter be severed such as by mechanical or thermal means, andthe closure catheter 38 is thereafter retracted from the treatment site.

In accordance with a further aspect of the present invention, theclosure catheter 38 is provided with a deployable patch 126, asillustrated in FIGS. 16 and 17. The patch 126 may comprise of any of avariety of materials, such as PTFE, Dacron, or others depending upon theintended use. Suitable fabrics are well-known in the medical device art,such as those used to cover endovascular grafts or other prostheticdevices.

The patch 126 is preferably carried by the distal sections 72 of theanchor support 62. In the illustrated embodiment, the tissue anchors 90are carried within the proximal section 70 of anchor support 62. In thismanner, as illustrated in FIG. 17, the patch 126 is automaticallyunfolded and positioned across the aperture 122 as the anchor supports62 are inclined into the anchor deployment orientation. The tissueanchor 90 may thereafter be advanced through the patch 126 and into thetissue plane 120 to tack the patch 126 against the opening 122.Alternatively, the tissue anchors may be deployed in a pattern whichsurrounds but does not penetrate the tissue patch. In this embodiment,the tissue anchors are preferably connected to the tissue patch such asby a suture. The tissue anchors may also both be connected to the patchor to each other by sutures and penetrated through the patch into thetarget tissue.

Tissue anchors 90 may be deployed proximally by pulling the deploymentwire 106. Alternatively, tissue anchors 90 with or without an anchorsuture 108, may be deployed from the proximal section 70 by a push wireaxially movably positioned within the proximal section 70. Tissueanchors 90 may be carried on an introducer 96 as has been discussedpreviously herein.

The patch 126 may be retained on the distal section 72 in any of avariety of ways, such as through the use of low strength adhesivecompositions, or by piercing the anchors 90 through the material of thepatch 126 during the catheter assembly process.

Referring to FIGS. 18 through 20, there is disclosed an alternate anchor90 in accordance with the present invention. The anchor 90 may beutilized to anchor a suture within a solid tissue mass, or, asillustrated in FIG. 20, to secure a graft or patch to a tissue plane.

Referring to FIG. 18, anchor 90 comprises a proximal end 130, a distalend 132 and a central lumen 134 extending therebetween. Central lumen134 allows the anchor 90 to be positioned on an introducer 96 as isillustrated in FIG. 19, and has been previously discussed.

The anchor 90 is provided with at a least first proximal projection 136and a second proximal projection 138. First and second proximalprojections 136 and 138 are designed to enlarge radially outwardly inresponse to axial compression of the anchor 90. Thus, in an uncompressedconfiguration such as that illustrated in FIG. 19, the first and secondproximal projections 136 and 138 extend generally in parallel with thelongitudinal axis of the anchor 90. A distally facing tissue contactsurface 144 is forced to incline radially outwardly in response to axialshortening of the anchor 90, as will be apparent to those of skill inthe art in view of the illustration in FIG. 18. Although illustratedwith two proximal projections positioned at approximately 180° apartfrom each other, three or four or more proximal projections may beprovided, preferably evenly distributed about the circumference of theanchor 90.

At least a first distal projection 140, and preferably a second distalprojection 142 are provided on the tubular body 92 spaced distally apartfrom the proximal projections. First and second distal projections 140and 142 similarly expand or enlarge radially outwardly in response toaxial compression of the anchor 90. Axial separation between the firstproximal projection 136 and first distal projection 140 allows theanchor 90 to secure a patch 126 or graft or other structure to a tissueplane 120 as illustrated in FIG. 20, by sandwiching the patch 126 andtissue plane 120 between distally facing tissue contact surface 144 andproximally facing tissue contact surface 146. The anchor 90 can bedeployed from the introducer 96, utilizing any of the deploymentcatheters disclosed elsewhere herein.

The radial enlargement of the proximal and distal projections isaccomplished by axially shortening the anchor 90 along its longitudinalaxis. This may be accomplished by preventing proximal movement ofproximal end 130 by seating the proximal end 130 against the proximalsection 98 of an introducer 96, such as illustrated in FIG. 19. Thedistal end 132 is thereafter advanced proximally, such as by proximaltraction on a proximal force transmitter 148 which may be a suture 150.Suture 150 may extend in a loop through a plurality of apertures 152,extending through the proximal and distal projections. Alternatively,the suture 150 may extend alongside the anchor 90 or through centrallumen 134 depending upon the tolerance between the central lumen 134 andthe introducer 96. Alternative proximal force transmitter structures mayalso be utilized, as will be apparent to those of skill in the art.

The anchor 90 may be manufactured in a variety of ways, such as bycutting or etching from a metal or polymeric tube. Preferably, theanchor 90 is laser cut from a Nitinol or steel tube having an outsidediameter within the range of from about 0.014″ to about 0.038″ and anaxial length within the range of from about 0.050″ to about 0.250. Theaxial length of each of the distally facing tissue contact surface 144and proximally facing tissue contact 146 is within the range of fromabout 0.010″ to about 0.060″. The wall thickness of the tube is withinthe range of from about 0.002″ to about 0.012″. Full axial compressionof most metal tube embodiments will bend the metal beyond its elasticlimit at each apex on the various projections, such that the suture 150may be removed from the anchor 190 following deployment and the anchorwill remain in its deployed (axially compressed) configuration asillustrated in FIG. 20.

Although illustrated primarily as an embodiment intended for attaching apatch or other membrane to a tissue plane, the anchor 90 illustrated inFIG. 18 may also be used to anchor a suture to a solid tissue mass asdiscussed previously herein. For this purpose, the anchor may besimplified to include only a first and second proximal projection 136and 138, or additional projections in the same plane as the first andsecond proximal projections. However, first and second distalprojections or additional projections may be added, depending upon thedesired pull force required to dislodge the anchor 90 from the implantedposition within the tissue.

The cardiac defects may be accessed via catheter through a variety ofpathways. An ASD or VSD may be accessed from the arterial circuit. Thecatheter is introduced into the arterial vascular system and guided upthe descending thoracic and/or abdominal aorta. The catheter may then beadvanced into the left ventricle (LV) through the aortic outflow tract.Once in the LV, the patch may be deployed in the VSD. Alternatively,once in the LV, the patch may be directed up through the mitral valveand into the left atrium (LA). When the patch is in the LA, it may bedirected into the ASD and installed.

Alternatively, an ASD or VSD may be accessed from the venous circuit.The catheter with a patch thereon may be introduced into the venoussystem, advanced into the Inferior Vena Cava (IVC) or Superior Vena Cava(SVC) and guided into the right atrium (RA). The patch may then bedirected into the ASD. Alternatively, once in the RA, the patch may beadvanced through the tricuspid valve and into the right ventricle (RV)and directed into the VSD and installed.

Referring to FIGS. 21A-21G, there are illustrated a variety of tissueanchors which may be used in the tissue closure or attachment device ofthe present invention. Each of FIGS. 21A and 21B disclose an anchorhaving a body 92, a distal tip 101, and one or more barbs 94 to resistproximal movement of the anchor. An aperture 107 is provided to receivethe anchor suture. The embodiments of FIGS. 21A and 21B can be readilymanufactured such as by stamping or cutting out of flat sheet stock.

The anchor illustrated in FIG. 21C comprises a wire having a body 92 anda distal tip 101. The wire preferably comprises a super-elastic alloysuch as Nitinol or other nickel titanium-based alloy. The anchor iscarried within a tubular introducer, in a straight orientation, forintroduction into the tissue where the anchor is to reside. As the body92 is advanced distally from the carrier tube, the anchor resumes itslooped distal end configuration within the tissue, to resist proximalretraction on the wire body 92.

FIG. 21D illustrates a tubular anchor, which may be manufactured from asection of hypotube, or in the form of a flat sheet which is thereafterrolled about a mandrel and soldered or otherwise secured. The anchorcomprises a distal tip 101, one or more barbs 94, and an aperture 107for securing the anchor suture. The anchor of FIG. 21D may be carried byand deployed from the interior of a tubular anchor support as has beendiscussed. Alternatively, the anchor of FIG. 21D can be coaxiallypositioned over a central tubular or solid anchor support wire.

FIG. 21E illustrates an anchor which may be formed either by cuttingfrom tube stock or by cutting a flat sheet such as illustrated in FIG.21F which is thereafter rolled about an axis and soldered or otherwisesecured into a tubular body. In this embodiment, three distal tips 101in the flat sheet stock may be formed into a single distal tip 101 inthe finished anchor as illustrated in FIG. 21E. One or more barbs 94 maybe formed by slotting the sheet in a U or V-shaped configuration asillustrated. The anchor in FIG. 21E is additionally provided with one ormore barbs 95 which resist distal migration of the anchor. This may bedesirable where the anchor is implanted across a thin membrane, or inother applications where distal as well as proximal migration isdesirably minimized.

Although the present invention has been described in terms of certainpreferred embodiments, other embodiments will become apparent to thoseof skill in the art in view of the disclosure herein. Accordingly, thescope of the invention is not intended to be limited by the specificdisclosed embodiments, but, rather, by the attached claims.

What is claimed is:
 1. A method of patching an atrial septal defect,comprising the steps of: providing a catheter having an elongate,flexible body with a proximal end and a distal end, a patch and at leasttwo anchors removably carried by the distal end; advancing the distalend to a position near the atrial septal defect; positioning the patchacross the defect; and deploying the anchors from the catheter to securethe patch across the defect.
 2. A method of patching an atrial septaldefect as in claim 1, wherein the positioning step comprises enlargingthe cross section of the patch from a reduced profile for advancing thecatheter to an enlarged profile for patching the defect.
 3. A method ofpatching an atrial septal defect as in claim 1, wherein the positioningstep comprises inclining at least one patch support from an axialorientation to an inclined orientation to position the patch across thedefect.
 4. A method of patching an atrial septal defect as in claim 3,wherein the positioning step comprises inclining at least three patchsupports from an axial orientation to an inclined orientation toposition the patch across the defect.
 5. A method of patching an atrialseptal defect as in claim 3, wherein the deploying the anchors stepcomprises advancing the anchors distally through the patch and intotissue adjacent the defect to secure the patch across the defect.
 6. Amethod of closing an opening in a subcutaneous tissue plane, comprisingthe steps of: providing a catheter having a longitudinal axis, a patchand at least one anchor thereon; advancing the catheter to the opening;positioning the patch across the opening such that the patch isapproximately parallel to the tissue plane and transverse to thelongitudinal axis; and advancing the anchor into tissue to secure thepatch across the opening.
 7. A method of closing an opening in asubcutaneous tissue plane as in claim 6, wherein the advancing theanchor step comprises advancing the anchor through the patch and intothe tissue.
 8. A method of closing an opening in a subcutaneous tissueplane as in claim 6, wherein the advancing the anchor step comprisesadvancing at least three anchors into the tissue to secure the patchacross the opening.
 9. A method of closing an opening in a subcutaneoustissue plane as in claim 6, wherein the opening is a naturally occurringopening.
 10. A method of closing an opening in a subcutaneous tissueplane as in claim 9, wherein the opening is an atrial septal defect. 11.A method of closing an opening in a subcutaneous tissue plane as inclaim 6, wherein the opening is a surgically created opening.
 12. Amethod of closing an opening in a subcutaneous tissue plane as in claim6, further comprising the step of unfolding the patch from a reducedconfiguration to an enlarged configuration prior to the advancing theanchor step.
 13. A deployment catheter for deploying a patch across atissue aperture, comprising: an elongate body, having a proximal end anda distal end; at least one patch support for removably carrying a patch;and at least one anchor support hingeably connected to the patch supportfor removably carrying at least one anchor.
 14. A deployment catheter asin claim 13, wherein the anchor support is movable between an axialorientation and an inclined orientation with respect to a longitudinalaxis of the body.
 15. A deployment catheter as in claim 14, wherein theanchor support is hingably connected to the patch support.
 16. Adeployment catheter as in claim 15, comprising at least four anchorsupports and at least four patch supports.
 17. A deployment catheter asin claim 14, further comprising a control on the proximal end of thebody, wherein the anchor support is movable from the axial orientationto the inclined orientation in response to manipulation of the control.18. A patch deployment catheter for deploying a patch across an opening,comprising: an elongate body, having a proximal end and a distal end; atleast two supports on the catheter, movable between an axial orientationand an inclined orientation, each support comprising a proximal section,a distal section, and a hinge in between; and a control on the catheterfor moving the hinge radially outwardly from a first position forintroducing the catheter to a site in the body to a second position fordeploying the patch at the site; wherein the supports are in the axialorientation when the hinge is in the first position.
 19. A patchdeployment catheter as in claim 18, wherein the body is flexible.
 20. Apatch deployment catheter as in claim 18, further comprising at leastone tissue anchor carried by the proximal section of each support.
 21. Apatch deployment catheter as in claim 18, further comprising at leastone patch carried by the distal section of each support.
 22. A patchdeployment catheter as in claim 21, comprising a tissue ingrowth surfaceon the patch.
 23. A patch deployment catheter as in claim 20, whereinthe proximal section comprises a tube and the tissue anchor is removablycarried inside of the tube.
 24. A patch deployment catheter as in claim23, further comprising a deployment actuator extending throughout thelength of the catheter, and the tissue anchor is advanced distally outof tube in response to axial movement of the actuator.